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Biotech / Medical : Geron Corp.
GERN 1.240-0.8%10:41 AM EST
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To: Savant who wrote (3194)2/1/2011 2:40:39 AM
From: John Vosilla   of 3576
 
Stem Cell Therapy for Spinal Cord Injury
New Hope for Cure.
It has taken 12 years after the isolation of human embryonic stem cells to move from discovery to human clinical trials in the US. FDA approval of Phase I trial for Geron embryonic stem cells for spinal cord injury is a milestone. This trial started in October 2010. A month later FDA cleared the Advanced Cell Technology stem cells for Phase I trials. FDA had approved the start of Phase I trials with human neural stem cells in 2008. Taking the analogy from monoclonal antibodies, the first stem cell treatment may reach the market by after 2018. The attrition rate of new technology and therapy is much higher for the first generation products. If stem cell treatment pass the current criteria for safety and efficacy in clinical trial and are not associated with any new toxicity or risk, then a new market opportunity is created. FDA/EMA regulatory guidelines and regulations are evolving to ensure the safety of the product in clinical trial and are not associated with any new toxicity or risk, then a new market opportunity is created. FDA/EMA regulatory guidelines and regulations are evolving to ensure the safety of the products in clinical testing. Several of the first generation investigational cells have received fast track and orphan drug designation from the FDA/EMA. Like the monoclonal antibody market of $ 40 billion in 2009, stem cell therapy may generate similar revenues 12 years after first approval and give rise to several blockbuster products. The first stem cell MAA dossier may be filed for approval with EMA and likely to be approved during 2011. FDA started the new year 2011 by approving the second Phase I trial of Advanced Cell Technology for vision loss in older persons due to Dry Age related Macular Degeneration AMD.

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